Allergies

Business

FDA Delays Aquestive's Anaphylm Epinephrine Film, Demands Human Factors Revisions

The FDA has issued a complete response letter for Aquestive Therapeutics' sublingual epinephrine film Anaphylm, citing concerns over packaging and user instructions. The company aims to address the issues and resubmit its application by the third quarter of this year.

FDA Rejects Aquestive's Oral Anaphylaxis Treatment, Leaving Patients Awaiting Epinephrine Alternative

The U.S. Food and Drug Administration has issued a complete response letter for Aquestive Therapeutics' oral film drug designed to treat severe allergic reactions, the company announced Monday, delaying a potential new option for millions at risk.

Business

GSK Bolsters Pipeline with RAPT Buy, Expands RSV Vaccine to All Adults in Europe

GSK makes a dual strategic move, acquiring RAPT Therapeutics for its food allergy portfolio and securing broader European approval for its RSV vaccine Arexvy, reinforcing its focus on immunology and respiratory health.